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U.S. Food & Drug Administration
10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 0 5
Silver Spring, MD 20993
www.fda.gov
July 10, 2019
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Yanhong Bai
Manager Regulatory Affairs
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen, 518057, P.R. China
Re: K190011
Trade/Device Name: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
Regulation Number: 21 CFR 870.1025
Regulation Name: Arrhythmia Detector and Alarm (including ST-Segment Measurement and Alarm)
Regulatory Class: Class II
Product Code: MHX, DQA, DRT, DSI, DSK, DXN, FLL, MLD, DPZ, CCK, CBQ, CBS, CBR, CCL,
DSB, DXG, OLW, DSJ, KOI, GXY
Dated: June 6, 2019
Received: June 10, 2019
Dear Yanhong Bai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
K190011 - Yanhong Bai Page 2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole Goodsell
Assistant Director
DHT2A: Division of Cardiac
Electrophysiology, Diagnostics
and Monitoring Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
for
FORM FDA 3881 (7/17) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
510(k) Number (if known)K190011
Device NamePassport Series Patient Monitors (including Passport 12m,Passport 17m and T1)
Indications for Use (Describe)Passport 12m and 17m Patient Monitors: The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only; • ST Segment analysis of Mindray algorithm is intended for adult patients only; • C.O. monitoring is restricted to adult patients only; • ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use. T1 Patient Monitor: The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients; • ST Segment analysis of Mindray ECG algorithm is intended for adult patients only. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
FORM FDA 3881 (7/17) Page 2 of 2
This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) [email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”
MINDRAY©PROPRIETARY Page 1 of 26 Patient Monitors
510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Passport Series Patient Monitors is provided below.
Device Common Name: Patient Monitor
Device Proprietary Name: Passport Series Patient Monitors (Passport 12m, Passport 17m and T1)
Submitter
Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China Tel: +86 755 8188 8998 Fax: +86 755 2658 2680
Contact
Ms. Yanhong Bai Manager Regulatory Affairs Shenzhen Mindray Bio-medical Electronics Co., LTD. Mindray Building, Keji 12th Road South, High-tech Industrial Park, Nanshan, Shenzhen 518057, P.R. China Tel: +86 755 81885635 Fax: +86 755 26582680 E-mail: [email protected]
Date Prepared
December 31, 2018 Classification Regulation
21 CFR 870.1025, Class II, Arrhythmia detector and alarm (including ST-segment measurement and alarm)
Panel
Cardiovascular
MINDRAY©PROPRIETARY Page 2 of 26 Patient Monitors
Classification Regulation, Classification Name and Product Codes:
Product Code
Regulation Number
Panel Regulation description Device Common Name
Primary MHX 21 CFR
870.1025 Cardiovascular Arrhythmia detector and
alarm (including ST-segment measurement and alarm)
monitor, physiological, patient(with arrhythmia detection or alarms)
Secondary Product Code
Regulation Number
Panel Regulation description Device Common Name
DSI 21 CFR 870.1025
Cardiovascular Arrhythmia detector and alarm (including ST-segment measurement and alarm)
detector and alarm, arrhythmia
MLD 21 CFR 870.1025
Cardiovascular Arrhythmia detector and alarm (including ST-segment measurement and alarm)
monitor, st segment with alarm
DRT 21 CFR 870.2300
Cardiovascular Cardiac Monitor (including cardiotachometer and rate alarm)
monitor, cardiac (incl. cardiotachometer & rate alarm)
DXN 21 CFR 870.1130
Cardiovascular Noninvasive blood pressure measurement system
system, measurement, blood-pressure, non-invasive
DSK 21 CFR 870.1110
Cardiovascular Blood pressure computer computer, blood-pressure
FLL 21 CFR 880.2910
Cardiovascular Clinical electronic thermometer
thermometer, electronic, clinical
DQA 21 CFR 870.2700
Cardiovascular Oximeter oximeter
DPZ 21 CFR 870.2710
Cardiovascular Ear oximeter oximeter, ear
CCK 21 CFR 868.1400
Anesthesiology Carbon dioxide gas analyzer
analyzer, gas, carbon-dioxide, gaseous-phase
CBQ 21 CFR Anesthesiology Enflurane gas analyzer analyzer, gas, enflurane,
MINDRAY©PROPRIETARY Page 3 of 26 Patient Monitors
868.1500 gaseous-phase (anesthetic concentration)
CBS 21 CFR 868.1620
Anesthesiology Halothane gas analyzer analyzer, gas, halothane, gaseous-phase (anesthetic conc.)
CBR 21 CFR 868.1700
Anesthesiology Nitrous oxide gas analyzer analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.)
CCL 21 CFR 868.1720
Anesthesiology Oxygen gas analyzer analyzer, gas, oxygen, gaseous-phase
DSB 21 CFR 870.2770
Cardiovascular Impedance plethysmograph
plethysmograph, impedance
DXG 21 CFR 870.1435
Cardiovascular Single-function, preprogrammed diagnostic computer
computer, diagnostic, pre-programmed, single-function
OLW 21 CFR 882.1400
Neurology Electroencephalograph index-generating electroencephalograph software
DSJ 21 CFR 870.1100
Cardiovascular Blood pressure alarm alarm, blood-pressure
KOI 21 CFR 868.2775
Anesthesiology Electrical peripheral nerve stimulator
stimulator, nerve, peripheral, electric
GXY 21 CFR 870.1320
Neurology Cutaneous electrode. electrode, cutaneous
Primary Predicate Device: K152902 - Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1) Shenzhen Mindray Bio-Medical Electronics Co., Ltd K170876 - Passport Series Patient Monitors (Passport 12m and Passport 17m) Shenzhen Mindray Bio-Medical Electronics Co., Ltd Secondary Predicate Device: K182075 -BeneVision N Series Patient Monitors
Shenzhen Mindray Bio-Medical Electronics Co., Ltd K171292 - A7 Anesthesia System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Indications for Use:
MINDRAY©PROPRIETARY Page 4 of 26 Patient Monitors
Passport 12m and 17m Patient Monitors:
The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, QT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only;
ST Segment analysis of Mindray algorithm is intended for adult patients only; C.O. monitoring is restricted to adult patients only; ICG monitoring is only for use on adult patients who meet the following
requirements: height: 122 to 229cm, weight: 30 to 155kg.
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
T1 Patient Monitor:
The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG.
All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;
ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.
MINDRAY©PROPRIETARY Page 5 of 26 Patient Monitors
The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.
Device Description: The subject Passport Series Patient Monitors includes three monitors:
Passport 12m Patient Monitor Passport 17m Patient Monitor T1 Patient Monitor
All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, alarming, and transferring multiple physiological parameters. The Passport 12m and 17m Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor. The T1 patient monitor is one of the available modules that can be plugged into the Passport 17m or 12m monitor. The T1 can also be used as a standalone monitor and when used as a standalone monitor, it provides a subset of the functions that are provided by Passport 17m and 12m. Substantial Equivalence: Comparison of Indications The indications for use of the subject devices have not changed in this 510(K). Indications of the predicate device (Passport 12m and 17m Patient Monitors K170876,T1 Patient Monitor K152902) and the subject device (Passport 12m,Passport 17m and T1)) are the same. Comparison of Technological Characteristics The table below compares the key technological feature of the subject devices to the primary predicate device (Passport 12m and 17m Patient Monitors K170876, T1 Patient Monitor K152902). The features in grey are the features that have been modified since their previous clearances and that are the subject of this 510(k). Device Comparison Table (Compare with Passport 12m and 17m Patient Monitors K170876,T1 Patient Monitor K152902)
MIN
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6 o
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Patie
nt M
onito
rs
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Inte
grat
ed d
ispl
ay
and
touc
hscr
een
17”,
12
80*1
024
pixe
ls
12”,
800
*600
pix
els
5”,
480*
272
pixe
ls
Sam
e Sa
me
Sam
e
Seco
ndar
y di
spla
y In
depe
nden
t co
ntro
l an
d di
spla
y D
ispl
ay i
s lin
ked
to
inte
grat
ed d
ispl
ay
Inde
pend
ent
disp
lay
and
cont
rol
via
a V
GA
por
t in
the
T1
do
ckin
g st
atio
n
Sam
e Sa
me
Sam
e
Add
ition
al d
ispl
ay
feat
ures
The
min
itren
ds d
iagr
am,
Oxy
CR
G d
iagr
am,
othe
r m
onito
r vi
ew, a
nd c
alcu
latio
n ca
n be
vie
wed
whe
n us
ing
an e
xter
nal
LCD
scre
en
Sam
e
Wire
less
mod
ule
The
ASU
S m
odul
e is
us
ed f
or c
onne
ctin
g to
a
netw
ork
wire
less
ly,
cons
truct
ing
a m
onito
ring
netw
ork
with
a
cent
ral
mon
itorin
g sy
stem
(C
MS)
.
The
ASU
S,
Sile
x an
d La
ird m
odul
es
are
used
fo
r co
nnec
ting
to
a ne
twor
k w
irele
ssly
, co
nstru
ctin
g a
mon
itorin
g ne
twor
k w
ith
a ce
ntra
l m
onito
ring
syst
em
(CM
S).
The
Cyb
erlin
k m
odul
es is
use
d fo
r co
nnec
ting
to
a ne
twor
k w
irele
ssly
, co
nstru
ctin
g a
mon
itorin
g ne
twor
k w
ith a
ce
ntra
l m
onito
ring
syst
em (C
MS)
.
Sam
e Sa
me
Laird
(2
.4G
Hz/
5GH
z)
wire
less
mod
ule
is ad
ded
MIN
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Patie
nt M
onito
rs
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Mod
ule
rack
In
depe
nden
t of t
he p
atie
nt m
onito
r, pr
ovid
es
8 st
anda
rd
mod
ule
slot
s to
ex
tend
th
e m
easu
rem
ent c
apab
ilitie
s of t
he sy
stem
N
ot su
ppor
ted
Sam
e Sa
me
Pow
er su
pply
Tw
o re
char
geab
le
Lith
ium
-ion
batte
ry
or A
C p
ower
supp
ly
One
re
char
geab
le
Lith
ium
-ion
batte
ry
or A
C p
ower
supp
ly
One
rec
harg
eabl
e Li
thiu
m-io
n ba
ttery
or
D
C
pow
er s
uppl
y or
A
C p
ower
supp
ly
Sam
e Sa
me
Sam
e
Bat
tery
C
harg
eabl
e Li
thiu
m-Io
n, 1
1.1
VD
C,
4500
m
Ah,
350
g
Cha
rgea
ble
Lith
ium
-Ion
, 7.
4 V
DC
, 250
0 m
Ah
Sam
e Sa
me
Exte
rnal
mem
ory
card
C
ompa
ct F
lash
Se
cure
Dig
ital
Sam
e Sa
me
Dat
a R
ecor
der
The
ther
mal
re
cord
er
reco
rds
patie
nt
info
rmat
ion,
mea
sure
men
t nu
mer
ics,
up t
o th
ree
wav
efor
ms,
etc.
N
ot su
ppor
ted
Sam
e Sa
me
Spea
ker
Giv
e al
arm
tone
s (45
to 8
5 dB
), ke
y to
nes,
QR
S to
nes;
supp
ort
PITC
H T
ON
E an
d m
ulti-
leve
l ton
e m
odul
atio
n Sa
me
Supp
orts
T1
as a
m
odul
e Su
ppor
ted
/ Sa
me
Sam
e
Supp
orts
N1
as a
m
odul
e N
ot su
ppor
ted
Not
supp
orte
d Su
ppor
ted
Sam
e
MIN
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Patie
nt M
onito
rs
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
MPM
mod
ule
MPM
2.0
mod
ule,
it su
ppor
t: 3/
5/12
lead
EC
G, N
IBP,
dua
l cha
nnel
Tem
p,
SpO
2, d
ual c
hann
el IB
P m
easu
rem
ent
/
MPM
3.0
mod
ule
is a
dded
, it
supp
ort:
3/5/
12 l
ead
ECG
, N
IBP,
dua
l ch
anne
l Te
mp,
Sp
O2,
du
al
chan
nel I
BP
mea
sure
men
t W
hen
MPM
3.0
mod
ule
is us
ed
with
Pas
spor
t 12m
and
17m
, the
fu
nctio
nalit
y an
d pe
rfor
man
ce is
sa
me
with
MPM
2.0
mod
ule.
/
ECG
3-le
ad ,
5-le
ad o
r 12-
lead
sel
ecta
ble,
arr
hyth
mia
det
ectio
n, S
T se
gmen
t an
alys
is,
QT
anal
ysis
, he
art
rate
(H
R),
an
inte
rpre
tatio
n of
rest
ing
12-le
ad E
CG
, J-p
oint
Aut
o de
tect
ion,
D
ual
Cha
nnel
Pac
e de
tect
ion
and
Adj
usta
ble
QR
S D
etec
tion
Thre
shol
d
Sam
e
Arr
hyth
mia
A
naly
sis
(Min
dray
A
lgor
ithm
)
Asy
stol
e, V
Fib/
VTa
c, V
tac,
Ven
t. Br
ady,
Ext
rem
e Ta
chy,
Ex
trem
e B
rady
, PV
C, C
oupl
et, B
igem
iny,
Trig
emin
y, R
on
T,
Run
PV
Cs,
PVC
s, Ta
chy,
Bra
dy, M
isse
d B
eats
, Ven
t. R
hyth
m,
PNP,
PN
C, M
ultif
. PV
C,
Non
sus.
Vta
c, P
ause
, Irr
. Rhy
thm
, A
Fib
Sam
e
Arr
hyth
mia
A
naly
sis
(Mor
tara
A
lgor
ithm
)
Asy
stol
e, V
fib,
Vta
c, V
ent.
Rhy
thm
, C
oupl
et,
Run
PV
Cs,
Big
emin
y, T
rigem
iny,
R o
n T,
Mul
tif.
PVC
, Irr
. R
hyth
m,
Tach
y, B
rady
, Mis
sed
Beat
s, PN
P, P
NC
, PV
Cs
Sam
e
MIN
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f 26
Patie
nt M
onito
rs
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Res
pira
tion
rate
(R
esp)
Use
s th
e M
PM (
Mul
ti Pa
ram
eter
Mod
ule)
to
mea
sure
the
ch
ange
in im
peda
nce
mea
sure
d ac
ross
the
thor
ax to
det
erm
ine
the
resp
iratio
n ra
te.
Sam
e
Tem
pera
ture
(T
emp)
Use
s the
MPM
(Mul
ti Pa
ram
eter
Mod
ule)
to m
easu
re c
ore
and
skin
tem
pera
ture
. T
he p
atie
nt m
onito
r ca
n m
onito
r tw
o te
mpe
ratu
res s
imul
tane
ousl
y us
ing
ther
mal
ly se
nsiti
ve re
sist
ors
(ther
mis
tors
).
Sam
e
Puls
e ox
ygen
sa
tura
tion
(SpO
2)
Use
s the
MPM
(Mul
ti Pa
ram
eter
Mod
ule)
or t
he S
pO2
mod
ule
to m
easu
re th
e am
ount
of o
xyge
nate
d ha
emog
lobi
n an
d pu
lse
rate
by
mea
surin
g th
e ab
sorp
tion
of se
lect
ed w
avel
engt
hs o
f lig
ht.
Is c
ompa
tible
with
the
follo
win
g 3
mod
ules
to m
easu
re o
xyge
n sa
tura
tion:
M
indr
ay S
pO2 M
odul
e
Mas
imo
SpO
2 Mod
ule
N
ellc
or S
pO2 M
odul
e
Sam
e
MIN
DR
AY©PR
OPR
IETA
RY
Page
10
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Puls
e ra
te (P
R)
PR fr
om M
indr
ay S
pO2
Mea
sure
men
t ran
ge: 2
0 to
254
bpm
A
ccur
acy:
±3 b
pm
PR fr
om M
asim
o Sp
O2
Mea
sure
men
t ran
ge: 2
5 to
240
bpm
A
ccur
acy:
±3 b
pm (m
easu
red
with
out m
otio
n)
±5 b
pm (m
easu
red
with
mot
ion)
PR
from
Nel
lcor
SpO
2 M
easu
rem
ent r
ange
: 20
to 3
00 b
pm
Acc
urac
y:20
to 2
50 b
pm: ±
3 bp
m
251
to 3
00 b
pm, n
ot sp
ecifi
ed
PR fr
om IB
P M
easu
rem
ent r
ange
: 25
to 3
50 b
pm
Acc
urac
y:±1
bpm
or ±
1%, w
hich
ever
is g
reat
er
PR fr
om N
IBP
M
easu
rem
ent r
ange
: 40
to 2
40 b
pm
Acc
urac
y: ±
3 bp
m o
r ±3%
, whi
chev
er is
gre
ater
PR fr
om M
indr
ay S
pO2
Sam
e PR
from
Mas
imo
SpO
2 Sa
me
PR fr
om N
ellc
or S
pO2
Sam
e PR
from
IBP
Sam
e PR
from
NIB
P
Mea
sure
men
t ran
ge: 3
0 to
300
bpm
A
ccur
acy:
Sam
e
MIN
DR
AY©PR
OPR
IETA
RY
Page
11
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Non
-inva
sive
bl
ood
pres
sure
(N
IBP)
Mea
sure
men
t ran
ge:
A
dult:
Sy
stol
ic: 4
0-27
0 m
mH
g
Dia
stol
ic: 1
0-21
0 m
mH
g
Mea
n:20
-230
mm
Hg
Pe
diat
ric:
Syst
olic
:40-
200m
mH
g
D
iast
olic
:10-
150m
mH
g
M
ean:
20-1
65m
mH
g N
eona
te:
Syst
olic
:40-
135
mm
Hg
D
iast
olic
:10-
100m
mH
g
Mea
n:20
-110
mm
Hg
Acc
urac
y:
Max
mea
n er
ror:
±5 m
mH
g M
ax st
anda
rd d
evia
tion:
8 m
mH
g
Mea
sure
men
t ran
ge:
A
dult:
Sy
stol
ic: 2
5-29
0 m
mH
g
Dia
stol
ic: 1
0-25
0 m
mH
g
Mea
n:15
-260
mm
Hg
Pe
diat
ric:
Syst
olic
:25-
240m
mH
g
D
iast
olic
:10-
200m
mH
g
M
ean:
15-2
15m
mH
g N
eona
te:
Syst
olic
:25-
140
mm
Hg
D
iast
olic
:10-
115
mm
Hg
M
ean:
15-1
25 m
mH
g A
ccur
acy:
Sa
me
Inva
sive
bl
ood
pres
sure
(IB
P)
Use
s the
MPM
(Mul
ti Pa
ram
eter
Mod
ule)
or t
he IB
P M
odul
e to
mea
sure
inva
sive
blo
od p
ress
ure.
The
mon
itor c
an m
onito
r up
to 8
inv
asiv
e bl
ood
pres
sure
s an
d di
spla
ys s
ysto
lic, d
iast
olic
an
d m
ean
pres
sure
s an
d a
wav
efor
m
for
each
pre
ssur
e.
Supp
orts
the
PPV
func
tion.
Sam
e
MIN
DR
AY©PR
OPR
IETA
RY
Page
12
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Puls
e Pr
essu
re
Var
iatio
n (P
PV)
Supp
orte
d fe
atur
e of
IBP
Sam
e
Car
diac
ou
tput
(C
.O.)
The
tem
pera
ture
cha
nge
is d
ispl
ayed
as
a cu
rve
in t
he C
.O.
split
scr
een,
and
the
m
onito
r ca
lcul
ates
the
C.O
. val
ue fr
om th
is cu
rve.
The
mon
itor
is c
apab
le o
f st
orin
g 6
mea
sure
men
ts.
Not
supp
orte
d Sa
me
Sam
e
Con
tinuo
us
card
iac
outp
ut
(CC
O)
CC
O/S
vO2
inte
rfac
e m
odul
e is
used
to
in
terf
ace
with
Ed
war
ds
Vig
ilanc
e II
mon
itor
/ V
igile
o M
onito
r w
hich
m
easu
res
cont
inuo
us c
ardi
ac o
utpu
t (C
CO
) , m
ixed
ven
ous
oxyg
en s
atur
atio
n (S
vO2)
and
cent
ral v
enou
s ox
ygen
sa
tura
tion
(Scv
O2).
Not
supp
orte
d Sa
me
Sam
e
Cen
tral
veno
us
oxyg
en s
atur
atio
n (S
cvO
2)
ScvO
2 m
odul
e is
used
to
mea
sure
cen
tral
veno
us o
xyge
n sa
tura
tion
(Scv
O2).
N
ot su
ppor
ted
Sam
e Sa
me
MIN
DR
AY©PR
OPR
IETA
RY
Page
13
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Car
bon
diox
ide
(CO
2)
Is c
ompa
tible
with
the
follo
win
g 3
mod
ules
to m
easu
re c
arbo
n di
oxid
e:
Side
stre
am C
O2 M
odul
e
M
icro
strea
m C
O2 M
odul
e
Mai
nstre
am C
O2 M
odul
e C
O2
mon
itorin
g is
bas
ed o
n ca
lcul
atio
ns f
rom
m
easu
ring
the
abso
rptio
n of
inf
rare
d (IR
) lig
ht o
f spe
cific
wav
elen
gths
usi
ng
a ph
otod
etec
tor.
Side
stre
am C
O2
2.0
mod
ule
is
adde
d,
the
func
tiona
lity
and
perf
orm
ance
is
sa
me
with
Si
dest
ream
CO
2 1.
0 m
odul
e.
The
othe
r m
odul
es
and
spec
ifica
tions
rem
ains
the
sam
e.
Sam
e
Ane
sthe
tic
gas
(AG
)
Is c
ompa
tible
with
the
follo
win
g 2
mod
ules
to
mea
sure
Ane
sthe
tic g
as:
3-
slot
AG
Mod
ule
2-
slot
AG
Mod
ule
The
AG
mod
ule
anal
yzes
gas
sam
ples
from
th
e pa
tient
and
cal
cula
tes
CO
2, O
2, N
2O
and
AA
wav
es a
nd re
late
d nu
mer
ics,
airw
ay
resp
irato
ry
rate
, an
d M
AC
(m
inim
um
alve
olar
con
cent
ratio
n).
Supp
orts
the
3-sl
ot A
G m
odul
e.
Not
supp
orte
d Su
ppor
t Sa
mpl
e G
as R
ecyc
ling
feat
ure
for A
G m
odul
e Sa
me
MIN
DR
AY©PR
OPR
IETA
RY
Page
14
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Impe
danc
e ca
rdio
grap
h (IC
G)
U
ses
the
ICG
M
odul
e to
m
easu
re a
pat
ient
’s
hem
odyn
amic
sta
tus
usin
g a
non-
inva
sive
m
etho
d ba
sed
on
thor
acic
el
ectri
cal
bioi
mpe
danc
e (T
EB) t
echn
olog
y.
Not
supp
orte
d Sa
me
Sam
e
Bis
pect
ral
inde
x (B
IS)
Mea
sure
d pa
ram
eter
s: E
EG,
BIS
, B
IS L
, B
IS R
N
ot su
ppor
ted
Sam
e Sa
me
Res
pira
tion
mec
hani
cs (R
M)
M
easu
res
resp
iratio
n m
echa
nics
fo
r ad
ults
, pe
diat
rics
and
infa
nts.
Not
supp
orte
d Sa
me
Sam
e
MIN
DR
AY©PR
OPR
IETA
RY
Page
15
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
NM
T
Use
s the
NM
T m
odul
e to
mon
itor o
bjec
tive
neur
omus
cula
r tra
nsm
issi
on.
It ev
alua
tes
mus
cle
rela
xatio
n of
pat
ient
s un
der
neur
omus
cula
r bl
ock
by m
easu
ring
the
stre
ngth
of
m
uscl
e re
actio
n af
ter
elec
trica
lly s
timul
atin
g th
e de
dica
ted
mot
or
nerv
e.
Not
supp
orte
d Sa
me
Sam
e
MI N
DR
AY©PR
OPR
IETA
RY
Page
16
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
clea
ning
an
d di
sinf
ectin
g ag
ents
List
of a
gent
s
Sodi
um h
ypoc
hlor
ite b
leac
h H
ydro
gen
pero
xide
Is
opro
pano
l R
ely+
On
TMV
irkon
1-
Prop
anol
Pe
rfor
m
Mor
e ag
ents
are
add
ed
Met
rex
Cav
iCid
e1™
Vire
x I
I 256
Vire
x T
B
Alp
et D
2 Su
rfac
e Sa
nitiz
ing
Wip
es
Clo
rox
Dis
patc
h
Hos
pita
l C
lean
er
Dis
infe
ctan
t To
wel
s with
Ble
ach
Clo
rox
Hea
lthca
re B
leac
h G
erm
icid
al W
ipes
C
loro
x H
ealth
care
H
ydro
gen
Pero
xide
C
lean
er
Dis
infe
ctan
t Wip
es
Div
erse
y O
xivi
r T
B W
ipes
M
etre
x Ca
viW
ipes
™
PDI S
ani-C
loth
AF3
Ger
mic
idal
Dis
posa
ble
Wip
e PD
I San
i-Clo
th B
leac
h G
erm
icid
al D
ispo
sabl
e W
ipe
PDI S
ani-C
loth
HB
Ger
mic
idal
Dis
posa
ble
Wip
e PD
I San
i-Clo
th P
lus G
erm
icid
al D
ispo
sabl
e C
loth
PD
I Sup
er S
ani-C
loth
Ger
mic
idal
Dis
posa
ble
Wip
e V
IRA
GU
AR
D H
ospi
tal S
urfa
ce D
isinf
ecta
nts
MIN
DR
AY©PR
OPR
IETA
RY
Page
17
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Supp
ort
new
M
asim
o Sp
O2
acce
ssor
ies
Not
supp
orte
d
Add
ed:
040-
0033
78-0
0 R
D S
ET M
D 1
4-05
, PC
5 ft
04
0-00
3379
-00
RD
SET
MD
14-
12,
Patie
nt C
able
12
ft
040-
0033
10-0
0 8p
in m
asim
o C
able
RD
SET
04
0-00
3426
-00
LNC
S to
RD
Ada
pter
04
0-00
3381
-00
RD
to L
NC
Ada
pter
Cab
le
040-
0033
76-0
0 R
D
SET
DC
I, A
dult
Reu
sabl
e Se
nsor
04
0-00
3377
-00
RD
SET
DC
I, Pe
diat
ric R
eusa
ble
Sens
or
040-
0033
80-0
0 R
D
Set
TC-I
SpO
2 R
eusa
ble
Tip-
Clip
Ear
Sen
sor,
3ft
040-
0033
82-0
0 R
D S
ET A
dhes
ive
Sens
or
040-
0033
83-0
0 R
D S
ET P
DT
Adh
esiv
e Se
nsor
04
0-00
3384
-00
RD
Set
Infa
nt A
dhes
ive
Sens
or
040-
0033
85-0
0 R
D S
et N
eo A
dhes
ive
Sens
or
040-
0033
86-0
0 R
D S
et N
eoPt
Adh
esiv
e Se
nsor
04
0-00
3387
-00
RD
Se
t N
eoPt
-500
N
on-a
dhes
ive
sens
or
Supp
ort n
ew E
CG
ac
cess
orie
s N
ot su
ppor
ted
Add
ed
040-
0035
28-0
0 EC
G
cabl
e,
12-le
ad,
defib
rilla
tion-
proo
f, A
HA
MIN
DR
AY©PR
OPR
IETA
RY
Page
18
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Supp
ort n
ew C
O2
acce
ssor
ies
Not
supp
orte
d
Add
ed:
100-
0001
38-0
0 D
RYLI
NE
PRIM
E G
as S
ampl
ing
Line
With
Airw
ay A
dapt
er, A
dult/
Pedi
atric
10
0-00
0139
-00
DRY
LIN
E PR
IME
Gas
Sam
plin
g Li
ne W
ith A
irway
Ada
pter
, Neo
nate
10
0-00
0140
-00
RYLI
NE
PRIM
E+
Gas
Sa
mpl
ing
Line
With
Airw
ay A
dapt
er, A
dult/
Pedi
atric
10
0-00
0141
-00
DRY
LIN
E PR
IME+
Gas
Sam
plin
g Li
ne W
ith A
irway
Ada
pter
, Neo
nate
10
0-00
0142
-00
DRY
LIN
E PR
IME
Nas
al
Gas
Sa
mpl
ing
Line
, Adu
lt 10
0-00
0143
-00
DRY
LIN
E PR
IME
Nas
al
Gas
Sa
mpl
ing
Line
, Ped
iatri
c 10
0-00
0144
-00
DRY
LIN
E PR
IME
Nas
al
Gas
Sa
mpl
ing
Line
, Neo
nate
10
0-00
0145
-00
DRY
LIN
E PR
IME+
N
asal
G
as
Sam
plin
g Li
ne, A
dult
100-
0001
46-0
0 D
RYLI
NE
PRIM
E+
Nas
al
Gas
Sa
mpl
ing
Line
, Ped
iatri
c 10
0-00
0147
-00
DRY
LIN
E PR
IME+
N
asal
G
as
Sam
plin
g Li
ne, N
eona
te
100-
0001
51-0
0 D
RYLI
NE
PRIM
E W
ater
Tra
p M
ini
MIN
DR
AY©PR
OPR
IETA
RY
Page
19
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Impr
ove
the
SpO
2/C
O2/
BIS
si
gnal
co
rd
resi
stan
ce
to
dam
age
Not
supp
orte
d Su
ppor
ted
Not
e: T
1 do
esn’
t sup
port
BIS
mod
ule
Cor
rect
ed
an
issu
es
whe
re
NIB
P m
isre
porte
d “N
IBP
Exce
ssiv
e M
otio
n” a
fter
49
days
of r
unni
ng
Not
supp
orte
d Su
ppor
ted
MIN
DR
AY©PR
OPR
IETA
RY
Page
20
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
The
End
tidal
(Et)
and
Frac
tion
of
insp
ired
(Fi)
num
eric
s fo
r an
esth
etic
ag
ent
(AA
) ph
ysio
logi
cal
alar
ms
are
trigg
ed
only
w
hen
the
mon
itore
d pa
ram
eter
val
ue is
hi
gher
th
an
the
high
al
arm
lim
it or
is
low
er t
han
the
low
al
arm
lim
it
Not
supp
orte
d Su
ppor
ted
Sam
e
Exte
nd th
e se
tting
ra
nge
of
low
al
arm
lim
it of
Et
O2
Not
supp
orte
d Su
ppor
ted
Sam
e
MIN
DR
AY©PR
OPR
IETA
RY
Page
21
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Supp
ort
the
non-
over
lapp
ing
rela
tions
hips
of
al
arm
lim
it se
tting
of
ph
ysio
logi
cal
alar
ms
Not
supp
orte
d Su
ppor
ted
Supp
ort
re-a
larm
ing
afte
r a
phys
iolo
gica
l al
arm
is re
set
Not
supp
orte
d Su
ppor
ted
Supp
ort
pass
wor
d pr
otec
tion
for
acce
ssin
g th
e A
larm
Se
tup
men
u
Not
supp
orte
d Su
ppor
ted
Supp
ort
auth
oriz
atio
n of
th
e us
er
via
the
LDA
P
Not
supp
orte
d Su
ppor
ted
Supp
ort
the
Faci
lity
info
rmat
ion
of
patie
nt m
onito
r
Not
supp
orte
d Su
ppor
ted
MIN
DR
AY©PR
OPR
IETA
RY
Page
22
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Supp
ort t
he R
oom
N
o.
info
rmat
ion
of p
atie
nt m
onito
r N
ot su
ppor
ted
Supp
orte
d
Supp
ort
the
Vis
it N
umbe
r in
th
e pa
tient
de
mog
raph
ics
Not
supp
orte
d Su
ppor
ted
Supp
ort
prin
ting
of t
he a
rrhy
thim
a se
tting
s in
repo
rts
Not
supp
orte
d Su
ppor
ted
Cha
nge
the
fact
ory
defa
ult
setti
ng o
f pr
inte
r pa
per s
ize
Not
supp
orte
d Su
ppor
ted
Supp
ort t
o di
spla
y th
e M
AC
add
ress
of
pat
ient
mon
itor
Not
supp
orte
d Su
ppor
ted
Supp
ort
the
disp
lay
mod
e of
ST
val
ues
in t
he
para
met
er ti
le
Not
supp
orte
d Su
ppor
ted
MIN
DR
AY©PR
OPR
IETA
RY
Page
23
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Supp
ort
encr
yptio
n of
pa
tient
pr
ivat
e in
form
atio
n se
nt
to th
e ne
twor
k
Not
supp
orte
d Su
ppor
ted
Supp
ort
Laird
2.
4GH
z/5G
Hz
Wifi
mod
ule
Supp
orte
d N
ot su
ppor
ted
Sam
e Su
ppor
ted
Supp
ort
adju
stm
ent
of t
he
ST
poin
t on
m
ultip
le
disp
laye
d le
ads
Supp
orte
d N
ot su
ppor
ted
Sam
e Su
ppor
ted
Supp
ort
QT
repo
rt pr
intin
g Su
ppor
ted
Not
supp
orte
d Sa
me
Supp
orte
d
Supp
ort
NIB
P m
easu
rem
ent
on
cloc
k Su
ppor
ted
Not
supp
orte
d Sa
me
Supp
orte
d
Supp
ort
netw
ork
appl
icat
ion
trans
mis
sion
pr
iorit
y se
tting
Supp
orte
d N
ot su
ppor
ted
Sam
e Su
ppor
ted
Supp
ort E
CG
bea
t an
nota
tion
Supp
orte
d N
ot su
ppor
ted
Sam
e Su
ppor
ted
MIN
DR
AY©PR
OPR
IETA
RY
Page
24
of 2
6 Pa
tient
Mon
itors
Pred
icat
e D
evic
e (P
assp
ort 1
2m a
nd 1
7m P
atie
nt M
onito
rs
K17
0876
T1
Patie
nt M
onito
r K
1529
02)
Subj
ect D
evic
es
Feat
ure
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Pass
port
17m
Pa
sspo
rt 1
2m
T1
Supp
ort
DN
S fo
r A
DT
and
LDA
P se
rver
add
ress
N
ot su
ppor
ted
Sam
e Su
ppor
ted
Cor
rect
ed
an
issu
es
whe
re t
he
Bed
N
o.
of
the
Pass
port
12m
/17m
is
ch
ange
d af
ter
T1
is
pulle
d ou
t of
th
e m
onito
rs
Not
supp
orte
d Sa
me
Supp
orte
d
MINDRAY©PROPRIETARY Page 25 of 26 Patient Monitors
Performance Data To establish the substantial equivalence of the Passport Series Patient Monitors
(Passport 12m, Passport 17m and T1), Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.
ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance IEC 60601-1-2 :2014 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests IEC 60601-2-25: 2011 (2nd edition) Particular requirements for the basic safety and essential performance of electrocardiographs IEC 60601-2-27:2011 (3rd edition) Particular requirements for the safety, including essential performance of electrocardiographic monitoring equipment ISO 80601-2-61:2011 Particular requirements for the basic safety and essential performance of pulse oximeter equipment IEC 80601-2-30:2009/AMD1:2013 Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers ISO 80601-2-56:2009 (First edition) Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement IEC 60601-2-34 (Third Edition): 2011 Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment ISO 80601-2-55 First edition 2011-12-15 Medical electrical equipment - Part
MINDRAY©PROPRIETARY Page 26 of 26 Patient Monitors
2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Substantial Equivalence Conclusion:
Based on the detailed comparison of specifications for each of the modifications to the previously cleared Passport Series devices, Passport 12m and Passport 17m (K170876) and relevant reference predicates, T1 (K152902) and relevant reference predicates, the performance testing results and conformance with applicable standards show that the Passport Series Patient Monitors (including Passport 12m, Passport 17m and T1) can be found substantially equivalent to the predicate devices.